Hundreds of face masks have been removed from Australia’s therapeutic goods register amid fears they don’t meet health and safety standards.
Face masks used to curb the spread of coronavirus in hospitals should be included on the Australian Register of Therapeutic Goods (ARTG).
As of July 30, 286 types of face masks had been remove from the ARTG, amid concerns the personal protective gear does not meet regulatory standards or could even increase the spread of disease.
Entries on the ARTG can be withdrawn by the supplier themselves or by the Therapeutic Goods Administration (TGA).
The TGA said of one supplier: ‘Single use surgical masks have not provided sufficient evidence to show compliance … Continued use of these particular surgical masks may increase the risk of spreading infections (including COVID-19) between individuals.’
If the product is withdrawn by the supplier voluntarily, no recall is issued.
‘The TGA holds no evidence that these devices failed to meet appropriate manufacturing standards or that they failed to perform as intended,’ the TGA explained.
‘The decision to cancel the ARTG entry was made solely by the sponsor.’
Most of the face masks were cancelled by the supplier, not the TGA.
The TGA said they are undertaking a post-market review of face masks included in the ARTG.
‘Due to a rapid increase in demand for the manufacturing, importation and sale of face masks, there has been an increase in medical device inclusions in the ARTG, with many manufactured and imported from overseas,’ the TGA said.
‘Concerns have been raised about the quality and effectiveness of some products, particularly face masks, including that they: are included in the ARTG but do not meet the legislative requirements for medical devices; or may not, or do not, perform as intended.’
According to the TGA, masks, gloves and gowns intended by the manufacturer for use in an Australian hospital setting should be included on the ARTG.
But masks, gloves and gowns not intended by the manufacturer for use in a hospital or clinical setting are not required to be included in the ARTG.